Merck and Pfizer announce two Phase III trials for avelumab

Germany’s Merck (MRK: DE) and US pharma giant Pfizer (NYSE: PFE) on Tuesday announced the opening of trial sites for an international Phase III study of avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with platinum-resistant/ refractory ovarian cancer.

Chris Boshoff, vice president and head of early development, translational and immuno-oncology at Pfizer Oncology, said: "There are limited treatment options for women with ovarian cancer, and the prognosis for women with platinum-resistant ovarian cancer is especially poor. We have observed encouraging signs of early clinical activity of avelumab in patients with platinum-resistant or platinum-refractory ovarian cancer, and we hope to build on these results next year through a planned Phase III study of avelumab in combination with platinum therapy in patients with previously-untreated ovarian cancer.”

This is the first Phase III study of a PD-L1 inhibitor investigated as a treatment for platinum-resistant/refractory ovarian cancer, the companies said in a joint statement. The alliance also announced that the US Food and Drug Administration has provided approval to move forward with a Phase III study of avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer. The first trial sites are expected to open shortly.